BELLUS Health Receives Clearance of U.S. IND for BLU-5937 Phase 2 Study in Chronic Cough Patients

- April 3rd, 2019

BELLUS Health ((TSX:BLU) has announced that the US Food and Drug Administration (FDA) has accepted Bellus’ investigational new drug (IND) application and advancing its Phase 2 study for BLU-5937 in chronic cough patients in the US. As quoted in the press release: We’re very pleased that our first interactions with U.S. regulators have been positive … Continued

BELLUS Health ((TSX:BLU) has announced that the US Food and Drug Administration (FDA) has accepted Bellus’ investigational new drug (IND) application and advancing its Phase 2 study for BLU-5937 in chronic cough patients in the US.

As quoted in the press release:

We’re very pleased that our first interactions with U.S. regulators have been positive and look forward to treating chronic cough patients with BLU-5937 shortly,” commented Roberto Bellini, President and CEO of BELLUS Health. “Unlike other P2X3 antagonists, BLU-5937 is highly-selective, meaning that it can potentially reduce coughing, with very little to no effect on taste.”

BELLUS Health expects to initiate the clinical Phase 2 study for BLU-5937 in chronic cough patients in mid-2019, with top-line results anticipated in mid-2020. This will be a randomized, double-blind, placebo-controlled crossover, and dose-escalation study to assess the efficacy, safety, and tolerability of BLU-5937, in addition to helping confirm the optimal dose regimen. Four doses of BLU-5937 will be tested: 25, 50, 100, and 200 mg twice-daily. The study is expected to be conducted in approximately 50 patients with refractory chronic cough at 10 to 12 clinical sites in the United States and the United Kingdom.

Phase 1 data reported in November 2018 showed that BLU-5937 is safe and well-tolerated, with very limited taste alterations at the anticipated therapeutic doses and a pharmacokinetic profile supporting twice-daily dosing.

Click here to read the full press release.

Is the biotech market the perfect mesh between the technology and pharmaceutical market?

 
Read our FREE outlook report below!
 

Get the latest Biotech Investing stock information

Get the latest information about companies associated with Biotech Investing Delivered directly to your inbox.

Biotech Investing

Select None
Select All

Leave a Reply